Aradigm Reports Successful Top-line Phase 2 Data with Inhaled Liposomal Ciprofloxacin for Cystic Fibrosis
Study demonstrates significant reduction in bacterial infection and improvement in lung function following two weeks of treatment. Once daily dosing regimen may bring added convenience to patients
HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced positive results from an open-label, two week efficacy and safety study of its once daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis (CF). The study conducted at leading CF centers in Australia and New Zealand enrolled a total of 22 patients.
The primary efficacy endpoint in this Phase 2 study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load. Data analysis in 21 patients who completed the study, demonstrated that the Pseudomonas CFU decreased by a mean 1.43 log over the 14-day treatment period (p<0.0001). Evaluation one week after study treatment was discontinued showed that the Pseudomonas bacterial density in the lung was still reduced by 1.02 log CFU from the baseline without additional antibiotic use. Pulmonary function testing as measured by the forced expiratory volume in one second (FEV1) showed a significant mean increase of 6.86 % from baseline after 14 days of treatment (p=0.04). The study drug was well tolerated, and there were no serious adverse events reported during the trial.
"Reduction of the burden of treatment with more conveniently administered products would be most welcomed by the cystic fibrosis community. It was therefore important in this study that, in addition to the successful clinical efficacy and safety outcomes, the patients found the once daily dosing regimen very convenient. This is a very attractive feature of the new product candidate," said Dr. John Wilson of The Alfred Hospital, Melbourne, Australia, a CF physician and the lead investigator on the study.
"We are excited with the magnitude of the efficacy response seen in this proof-of-concept study," said Tunde Otulana, M.D., Aradigm's Chief Medical Officer. "The size of the reduction in bacterial density and the improvement in FEV1 represent clinically meaningful changes in these CF patients. Our results compare well with data with other inhaled antibiotics following 14-day treatment in similar subpopulations of CF patients where more frequent dosing was required."
"We are very pleased with these Phase 2 data. The trial results will enable Aradigm to advance the development of our liposomal ciprofloxacin product for cystic fibrosis in the U.S., as well as pursue our strategy for other disease indications including bronchiectasis, and other geographical locations," said Igor Gonda, Ph.D., the Company's President and CEO.
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF. Aradigm's once a day novel inhaled formulation of ciprofloxacin delivered in liposomes is to be used for chronic maintenance therapy as it is expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects.
Aradigm will provide more details on the data from this Phase 2 study in a business update conference call scheduled for July 16, 2008. Further information regarding the call will be announced soon.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, pulmonary hypertension, asthma and COPD, inhalation anthrax infections and smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the advancement of product development, as well as the other risks detailed in from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the Company's Annual Report on Form 10-K, and quarterly reports on Form 10-Q. Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.